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Double-Blind, Randomized, Multicenter, Clinical Phase III Study to Evaluate the Efficacy and Safety of HX575 for the Treatment of Chemotherapy Associated Anemia in Cancer Patients

Phase 3
18 Years
Not Enrolling

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Trial Information

Double-Blind, Randomized, Multicenter, Clinical Phase III Study to Evaluate the Efficacy and Safety of HX575 for the Treatment of Chemotherapy Associated Anemia in Cancer Patients

Inclusion Criteria:

- Patients with a confirmed diagnosis of solid tumors

- Patients who receive cyclic palliative chemotherapy with a cycle duration of 1 -4
weeks (for at least 12 weeks) during the study

- Patients with chemotherapy associated anemia (hemoglobin < 10.0 g/dl at screening)

- Life expectancy of at least 6 months Age: > 18

- Eastern Cooperative Oncology Group performance status of 0, 1 or 2

- Serum ferritin greater or equal to 100 µg/l and/or saturated transferrin levels
greater or equal to 20 %

- Adequate renal function (serum creatinine below or equal to 2.0 mg/dl)

- Adequate hepatic function (bilirubin < 1.5 times upper limit of normal range

- Patients with ability to follow study instructions, likely to complete all required
visits and able to perform the quality of life assessment

- Written informed consent of the patient

Exclusion Criteria:

- Patients who receive curative intended chemotherapy

- Known primary or metastatic malignancy of the central nervous system

- Known primary or metastatic malignancy of bone marrow

- Primary hematologic disorder (e.g. myelodysplastic syndrome, sickle cell anemia,
hematological malignancy, acute leukemia)

- Thrombotic events during the last 6 months

- Suspicion or known PRCA (pure red cell aplasia)

- Transfusion of white blood cells or packed red blood cells (more than 2 packs) within
4 weeks and any transfusion of white blood cells or packed red blood cells within 2
weeks prior to randomization (visit 0)

- Anemia due to overt bleeding or hemolysis within 2 weeks before screening

- Erythropoietin or Darbepoietin therapy within 8 weeks before screening, including any
investigational form of erythropoietin (e.g. gene-activated erythropoietin, novel
erythropoiesis stimulating protein)

- Radiation therapy during the study, radiation therapy induced anemia

- Therapy with cyclosporine

- Chemotherapy which causes predictable treatment with peripheral-blood progenitor
therapy, e.g. G-CSF

- Clinical evidence of current uncontrolled hyperparathyroidism (serum parathyroid
hormone >1500 pg/mL)

- Major surgery within 14 days prior to randomization

- Treatment with antiepileptics within the last 5 years

- Previously diagnosed HIV or acute hepatitis infection

- Uncontrolled hypertension, defined as a diastolic blood pressure measurement >110mm
Hg during the screening period

- History of congestive heart failure (NYHA class III, IV)

- Unstable angina pectoris, active cardiac disease, cardiac infarction during the last
six months before screening

- Evidence of acute infectious disease or serious active inflammatory disease within
four weeks before screening (Visit -1) or during the screening/baseline period

- Known allergy to one of the ingredients of the test or reference products or
hypersensitivity to mammalian-derived products

- Pregnancy, breastfeeding women or women not using adequate birth control measures

- Patients who participate simultaneously in another clinical study or who have
participated in a study in the month preceding the start of this study or previously
randomized to this study (except studies with approved medications in an approved
indication, with an approved dosing regimen including approved treatment

- Suspicion of any non-compliance

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

To assess the efficacy and safety of HX575 in the treatment of chemotherapy associated anemia

Safety Issue:


Principal Investigator

Andrea Vetter, Dr.

Investigator Role:

Study Chair

Investigator Affiliation:

Hexal AG


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

November 2004

Completion Date:

December 2005

Related Keywords:

  • Anemia
  • Chemotherapy associated anemia in cancer patients
  • Anemia